PROTECTION OF HUMAN
SUBJECTS

ORIGINATOR: Vice Provost for Graduate Studies, Research and
Outreach

DATE: October 2002 (revised)

POLICY #84-2

I. APPLICABLE TO: All employees and students.

II. POLICY:

Safeguarding the rights and welfare of
subjects at risk in any research, development, or related activity is
the responsibility of the University. In order to provide for the
adequate discharge of this responsibility, it is the policy of the
University that no activity involving human subjects be undertaken
until those activities have been reviewed and approved according to
procedures established by the University Institutional Review
Board.

This process of review and approval includes
the consideration of the methods to be used in the collecting of
data, obtaining informed consent, and in protecting the
confidentiality of subjects. Since the "risks" to subjects are
affected by these procedures, it is the responsibility of the
principal investigator to be fully familiar with the Code of Federal
Regulations (45 CFR 46, November 2001), which governs the protection
of human subjects and which forms the basis of University policy. An
assurance by the principal investigator that approved procedures will
be followed in the conduct of activities involving human subjects is
a requirement of the application process.

The University of Rhode Island's Federalwide
Assurance (FWA) granted by the U. S. Department of Health and Human
Services requires that all human subject activities and all
activities of the Institutional Review Board, regardless of funding
source, be guided by the ethical principles recognized by the Code of
Federal Regulations. The Federalwide Assurance (FWA), the Code of
Federal Regulations governing the protection of human subjects, and
the University of Rhode Island's IRB Policies and Procedures can be
reviewed at the Office of the Director of Compliance in the Research
Office or at http://www.uri.edu/research/compliance/humansubj.htm.

Federal regulations require that research
involving human subjects be reviewed by, and receive the approval of,
the University's Institutional Review Board. However, the regulations
do provide streamlined procedures such as "exempt" or "expedited"
review for proposals that are of minimal risk to human subjects. The
Chair of the Institutional Review Board and the Director of
Compliance determine the category of review.

A calendar of IRB meetings shall be published
and distributed prior to the beginning of each semester. Materials
must be submitted at least two (2) weeks prior to an IRB meeting in
order to be considered for review by the convened board.

At its meeting of December 12, 2002 the
Faculty Senate delegated the authority for maintaining and modifying
the discretionary portions of the Protection of Human Subjects Policy
to the Institutional Review Board.